A surgical positioning system includes a flexible air-impermeable shell filled with beads that is wrapped against the patient and subjected to a vacuum to hold the patient in place. The shell includes rounded shoulder portions, on either side of a separately inflatable pillow, to envelop portions of the patient's neck and shoulders, tapered waist portion to provide easy access to a patient's forearms and lower lateral abdomen, and expanded wrist hand portion to cradle the patient's hands and thighs.
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13. A method of positioning the body of a patient in a selected position with a surgical positioning device, the method comprising:
positioning a flexible, air-impermeable, and bead-filled shell between a patient and a support, wherein the shell has an upper edge and a lower edge and opposing first and second lateral edges extending between the upper edge and the lower edge, wherein the shell further defines first and second shoulder support regions positioned along the upper edge, a recessed perineal access region along the lower edge, and first and second recessed waist portions along the lateral edges;
causing the first and the second shoulder support regions to be positioned at least partially around the patient's shoulders; and
evacuating air from within the shell such that the first and the second shoulder support regions engage each of the patient's respective shoulders.
1. A surgical positioning device for positioning the body of a patient, the device comprising:
a flexible, air-impermeable shell having a top wall and bottom wall joined at an outer periphery, the outer periphery having an upper edge, lower edge and opposing lateral edges extending between the upper and lower edges;
a plurality of beads positioned within the shell;
the shell having opposed shoulder portions adjacent to the lateral edges and the upper edge, the shoulder portions having dimensions sufficient to be wrapped over and at least partially engage a patient's shoulders, the upper edge adjacent each shoulder portion being at least partially arcuate;
the shell having opposed, laterally projecting, lower protuberances along the lateral edges proximate to the lower edge, and opposed waist portions located between the lower protuberances and shoulder portions, the waist portions together defining a transverse width between the lateral edges that is less than a transverse width between the lateral edges at the shoulder portions and less than a transverse width between the lateral edges at the lower protuberances.
9. A surgical positioning device for positioning a body of a patient, the device comprising:
a flexible, air-impermeable shell having a top wall and bottom wall joined at an outer periphery, the outer periphery having an upper edge, lower edge and opposing lateral edges extending between the upper and lower edges;
a plurality of beads positioned within the shell;
the shell having a lower wrist engaging portion, an upper shoulder and arm engaging portions, and a waist portion therebetween;
the waist portion having a variable waist width including a minimum waist width, the lower wrist engaging portion including opposed protuberances proximate to the lower edge and having a wrist engaging portion width greater than the minimum waist width, the upper shoulder and arm engaging portion having a shoulder width greater than the minimum waist width and extending lengthwise beyond where a patient's shoulders would be positioned;
whereby when a patient is positioned on the device with the patient's arms against the patient's torso, the upper shoulder and arm engaging portion can be wrapped upwardly against and over the patient's upper arms and over the top of the patient's shoulders, and the wrist engaging portion can be wrapped up against and over the patient's wrists or hands, with the patient's forearms in the area of the waist portion being uncovered and accessible to medical personnel.
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This invention relates to an improved positioning system for supporting, restraining and/or immobilizing a patient during medical treatment and, more particularly, for supporting, restraining and immobilizing a patient when in a supine position during surgery.
Vacuum actuated positioning aids or devices are utilized in the operating room for positioning patients in the supine, prone and lateral positions. They are frequently used when the patient is in the lateral position, i.e., on his or her side, for a multitude of surgical procedures, such as brain, chest, kidney, shoulder and hip surgery, to name a few. The devices typically comprise a flexible air impervious bag containing small particles or beads which consolidate into a rigid mass when the bag is evacuated. See, for example, U.S. Pat. No. 3,762,404 to Sakita and U.S. Pat. No. 5,906,205 to Hiebert. Devices according to the Hiebert patent are sold by Hug-U-Vac under the trademark HUG-U-VAC®.
More specifically, devices of this type typically are filled with thousands of tiny, elastically deformable, generally spherical, polystyrene or plastic beads. When the device is in the soft (unevacuated) condition, the beads are free to move around so that the device can be molded to the patient's body. When air is removed (using a vacuum source), atmospheric pressure forces the beads together into a solid mass, positioning yet immobilizing the patient in the selected position. Allowing air back into the device returns it to its initial soft condition, ready for re-use.
These positioning devices, sometimes referred to as bean bag positioners, typically have a generally square or rectangular shape and in some cases are provided with a U-shaped shoulder cutout located centrally along one edge. One line of bean bag and “vacuum pac” positioners is offered by SW Med-Source, P.O. Box 93115, Southlake, Tex. (www.swmedsource.com). SW Med-Source offers gel bean bag positioners as well. Another line of Olympic VAC-PAC® bean bag positioners is offered by Natus Medical Incorporated, 1501 Industrial Road, San Carlos, Calif. (www.natus.com).
Fabric-style devices also are used for positioning patients during exam or treatment. These devices typically are wrapped around one or more sections of the patient, and include one or more wide canvas flaps with adjustable VELCRO™ straps. The flaps may be detached/unwrapped to allow a particular area of the patient to be selectively exposed for treatment. See, for example, Natus' OLYMPIC PAPOOSE BOARDS™ (www.natus.com)
Foam pads and other positioning aids also are used to reduce pressure points and provide patient support during surgery.
There remains however a need for an improved positioning system for surgery in which the patient is in a supine position, especially surgeries in which the patient is supported on an inclined surgery table as, for example, when the patient is in the Trendelenburg, Reverse Trendelenburg or Lateral Oblique positions.
In the Trendelenburg position, the patient is laid flat on her back with her feet above her head. This position may be used during certain laparoscopic and other procedures such as colectomies, hysterectomies, prostatectomies and robotic procedures. In some procedures, the angle of incline is so steep that the patient is in a so-called Steep Trendelenburg position. In the Reverse Trendelenburg position, the patient is tilted in the opposite direction with his head above his feet.
Accordingly, it is desirable to provide an improved positioning system for patients positioned in a supine position during surgery, especially surgeries requiring the patient to be oriented in an inclined position rather than a perfectly horizontal supine position.
It also is desirable to provide an improved positioning system for certain types of surgeries including, for example, laparatomies, laparoscopic procedures, colorectal procedures, gynecological procedures, neurological procedures, cholecystectomies, Nissin Fundoplications and da Vinci procedures.
It is further desirable to provide an improved positioning system for supine patients with better head and neck support.
In one example, a surgical positioning device for positioning the body of the patient in a selected position includes a flexible and air-impermeable shell having an air-impermeable top wall joined with an air-impermeable bottom wall, the shell defining an air-impermeable outer periphery. The outer periphery of the shell includes an upper edge, a lower edge and opposing first and second lateral edges extending between the upper edge and lower edge, and defines a laterally extending midline extending between the opposing lateral edges. An upper portion of the shell extends between the laterally extending midline and the upper edge. A lower portion of the shell extends between the laterally extending midline and the lower edge. A central region for supporting the patient's torso straddles the laterally extending midline and extends between the upper portion and lower portion. The upper portion includes opposing first and second shoulder support regions positioned laterally outward of the central region and adjacent the upper edge for supporting the patient's respective shoulders.
In another example, the lower edge defines a longitudinally recessed perineal access region for providing access to the patient's perineal region.
In another example, the upper portion includes rounded shoulder portions each having a radius of curvature that generally increases as the shoulder portion extends laterally outwardly toward its respective lateral edge. The width of the device at the shoulder portions and at its widest point is such that the device may be wrapped up and partially over the shoulders and proximate to the neck of a patient lying in a supine position.
In one example, the device is filled with many small beads, allowing the device to be pliable and conform to a patient's anatomy.
In another example, the lower portion includes opposed wrist portions which project laterally outwardly near the lower edge of the device. The device has a width dimension at the wrist portions that allows the device to be wrapped upwardly to provide lateral support for a patient's hands, wrists and thighs when the patient is in a supine position.
In yet another example, the opposed lateral edges of the device include a tapered waist portion located between the wrist portions and a point proximate the midline to give the device a low profile in the vicinity of the patient's wrists, forearms and lower lateral abdomen so as to provide greater surgical access in these areas, IV access, and access for surgical instruments.
In yet another example, the upper portion provides an adjustable pillow portion to support the patient's neck and head.
A method of supporting the patient in a supine position includes positioning a flexible air-impermeable shell between a patient and a support, such as an operating table. The shell has an upper edge and a lower edge and opposing first and second lateral edges extending between the upper edge and lower edge. The shell defines a laterally extending midline extending between the opposing lateral edges, and includes first and second shoulder support regions positioned adjacent the upper edge and a longitudinally recessed perineal access region adjacent the lower edge. When the patient is in the supine position, the first and second shoulder support regions are folded upwardly to at least partially engage each of the patient's shoulders. The shell is then substantially evacuated such that the first and second shoulder support regions support and retain in place each of the patient's respective shoulders.
In another example, a method of supporting a patient includes urging first and second upper arm support regions of the shell to at least partially engage each of the patient's respective upper arms, such that when the shell is evacuated the first and second upper arm support regions at least partially matingly engage each of the patient's upper aims.
In a further example, a method of supporting a patient includes adjustably inflating the pillow portion to provide appropriate support for the patient's head and neck.
The foregoing and other objects, features and advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.
Referring to
Thickness (inches)
0.024, +5%, −0
ASTM D-751
Embossing
Plain
Weight (oz./yd.2)
17.5
(min.)
ASTM D-751
Volatility (% loss)
1.5
(max)
ASTM D-1203-86,
Method B
Elongation (%)
350-360
(min)
ASTM D-882
Elongate change after
Less than 10
ASTM D-882
14 days × 150° F. (%)
Breaking strength
44
ASTM D-882
factor (psi)
Tensile change after
Less than 10
ASTM D-882
14 days × 150° F. (%)
Graves tear (lbs.)
5.6
(min)
ASTM D-1004
Low temperature (° F.)
−20
(min)
ASTM D-1790
Dimensional stability
−5
(max)
ASTM D-1204
(%)
Specific gravity
1.21-1.23
ASTM D-792
Mildew resistance
Passes
California Bureau
ATCC No.
of Home Furnishings,
6275
Bulletin 128
Bacteria resistance
Passes
California Bureau
ATCC No.
of Home Furnishings,
6538, 4352
Bulletin 128
Hydraulic resistance
75
ASTM D-75 1
(psi)
Puncture resistance
34.3
California Bureau
(lbs.)
of Home Furnishings,
Bulletin 100
The bag 12 includes top and bottom opposing walls 14, 16 which are radio frequency welded, heat sealed or otherwise joined together at their upper, lower and lateral edges 18, 20, 22 for strength and airtightness. The bag's preferred width at its widest point is about 42 inches, which exceeds the shoulder width of most patients. The bag's preferred length at its longest point is about 46 inches, which corresponds generally to the distance between the neck and upper thighs of an average height patient. Thus, when the patient is placed in the supine position on the bag 12, as shown in
Referring again to
Lateral edges 22a, 22b each define opposed cut out portions 28a, 28b, and opposed projecting wrist supporting portions 30a, 30b. Wrist supporting portions 30a, 30b project outwardly to increase the width of the bag in the region proximate the lower edge 20. The width of the bag across the wrist supporting portions preferably is about 35 inches. The wrist supporting portions may be folded upwardly to provide lateral support for the patient's wrists and hands. They help secure the patient's wrists and hands against the side of the patient's body. The cut out portions 28a, 28b give the bag a tapered waist and low profile in the vicinity of the patient's arms so as to provide easy access to the patient's wrists and forearms for insertion of an IV, surgical access to the lower lateral abdomen, access for surgical instruments and other purposes.
The lower edge 20 preferably includes a central trapezoid-like cut out 32 to provide perineal access. The cut out 32 preferably conforms to perineal access cut outs sometimes used in operating room table designs to provide access for speculums, rectal instruments and the like.
As shown in
It will be appreciated that once the straps are secured to the operating table, the fixed attachment of the straps to the strap patches 34a, 34b, 34c (and effectively to the bag 12 as well), keep the bag from sliding laterally on the operating table as, for example, when the table is tilted laterally to place the patient in the Trendelenburg and Lateral Oblique position.
Before walls 14, 16 are joined together to form the enclosed bag 12, the bag is filled with a charge of elastically deformable plastic beads 42 (
The bottom wall 16 of the bag 12 is provided with a valve 44 (
As shown in
As shown best in
The pillow preferably is made of the same material as the bag 12 itself. The pillow may be inflated by a number of conventional techniques, one of which is a hand held inflation bulb 50 (
Referring to
With reference to
The positioning system envelops the patient's shoulders and a portion of her chest, creating a narrow channel around the patient's neck and shoulders to resist the tendency of the patient to slide either laterally or longitudinally on the inclined plane formed by the operating table. The system provides substantial bulk and mass in the area of the patient's shoulders to help hold the patient in place. The system's conformity to the patient's anatomy (lower back, spine, shoulder blades, etc.) contributes to hold the patient in place.
In using the surgical positioning system, the bag 12 is centered on the operating table 40, with the pillow 46 toward the head of the operating table, and securely fastened to the table using the fastening straps 38a, 38b, 38c. The straps may be secured to the side rails of the operating table. The bag is then smoothed out so that the internal beads 42 inside are evenly distributed. The disposable waterproof slipcover 54 is then placed over the bag 12 and tucked underneath.
The patient is then placed in the supine position on the bag with the neck and head resting on the pillow 46. In the case of smaller or shorter patients, the pillow can be folded forward before the patient is placed in position. The inflation bulb 50 is then used to inflate the pillow as much as necessary to support and position the patient's head/neck, typically in a neutral position for most surgeries.
The lateral sides of the bag are then folded upwardly to engage the sides, shoulders and upper arms, forearms and wrists of the patient. The lateral and superior sides are snugly packed against the patient to accommodate the natural contours thereof and provide a generally U-shaped cradle for the patient. The top of the bag conforms to the patient's posterior. While holding the patient and bag in the desired position, air is evacuated from the interior of the bag 12. Specifically, the female portion of the evacuation valve 44 is attached to the male portion and a vacuum source is connected to the end of the female portion to evacuate air from the interior of the bag. Evacuation is continued until the bag is firm to provide contoured support for the patient. When the desired level of support is achieved, the female portion is detached from the male portion and the vacuum source is detached from the female portion. The bag retains its conforming shape. It will be appreciated that many types of known valve/hose constructions can be used to create and release the vacuum.
Once the patient is secured, the operating table 40 may be inclined to place the patient in the Steep Trendelenburg, Reverse Trendelenburg, Oblique Lateral or other inclined position for surgery. The positioning system uses different techniques to immobilize the patient in a comfortable manner while avoiding the application of significant local pressure to any specific region. The system spreads the cradling/supporting force over a relatively wide surface area of the patient's anatomy and yet provides easy access to a large surface area of the patient's anatomy, including the patient's forearms and lower lateral abdomen. Significantly, the system retains the patient in place by engaging a wide surface area of the patient in a way that eliminates pressure points. The bag's low profile in the vicinity of the patient's forearms also allows surgical instruments to swing lower along the side of the patient and allows the tips of medical instruments in the abdomen to reach the inner aspect of the anterior abdominal wall with less interference from the side restraints of conventional systems. Yet, the positioning system maintains contact with a sizable surface area of the patient's anatomy, including the patient's shoulders, upper arms, forearms, hands, hips and thighs. Such surface contact provides a friction surface and contour fit to resist the tendency of the patient to slip or slide longitudinally relative to the bag.
The bag's overall design also provides protuberances or abutments that serve as longitudinal obstructions for portions of the patient's anatomy. These obstructions resist the gravity influenced tendency of the patient to slide or slip on the inclined operating table. For example, as shown in
The bag also is designed to create narrow channels to resist sliding movement of the patient relative to the bag and the operating table. More specifically, as shown best in
In view of the many possible embodiments to which the principles of the disclosed invention may be applied, it should be recognized that the illustrated embodiments are only preferred examples of the invention and should not be taken as limiting the scope of the invention. Rather, the scope of the invention is defined by the following claims. We therefore claim as our invention all that comes within the scope and spirit of these claims.
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